Apparatus and method for the preparation and administration of blood components

ABSTRACT

A dual chambered syringe includes: an inner barrel defining a first inner chamber, the inner barrel having an apertured stopper at its distal end, the inner barrel being open at its proximal end; a shaft adapted to fit within the inner barrel, the shaft having a distal end which is engageable with the aperture of the stopper; a device for controlling engaging and disengaging of the distal end of the shaft with the aperture of the stopper; an outer barrel concentric with the inner barrel defining a second inner chamber, the outer barrel having a distal end for receiving and dispensing fluids and a proximal end into which the distal end of the inner barrel is insertable into the second inner chamber; the apertured stopper engages the second inner chamber of the outer barrel and selectively prevents or permits the passage of fluids between the outer barrel second chamber and the inner barrel first chamber; the inner barrel having an engageable surface on its outside surface; and, the outer barrel having operatively associated therewith an engaging device for selective engagement and disengagement with the engageable surface on the inner barrel.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 15/987,626, filed May 23, 2018, which is a continuation applicationof U.S. application Ser. No. 15/293,384, filed Oct. 14, 2016, now U.S.Pat. No. 10,537,686, which is a continuation application of PCTApplication Serial No. PCT/US2015/26270, filed Apr. 17, 2015, whichclaims the benefit of priority to U.S. Provisional Patent ApplicationNo. 61/980,612, filed Apr. 17, 2014. The complete disclosures of theseapplications are hereby incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to an apparatus and method for preparingplatelets rich plasma (PRP) and delivering systems for one or morecomponents to the human skin.

BACKGROUND OF THE INVENTION

Skin rejuvenation is occupying a significant part in the aesthetic fieldas it is deals with wrinkles, scars, pores, pigmentation and skintextures. Various materials, chemical and biological, are used for thispurpose and a lot of delivery systems have been developed to assure aneffective delivery to the different layers of the skin.

Recently, platelet rich plasma or PRP is proving to be efficient forskin rejuvenation procedures. Platelets contain several growth factorsthat are necessary to the healing and tissue renewal process. Manyresearches have presented results of PRP used for rejuvenation that wasapplied topically to the face or injected to the deeper skin layers. Inaddition, the PRP treatment was combined in several more researches withenergy source treatments as ultrasound and fractional laser forimproving outcomes and decreasing healing time.

The current methods for applying PRP are still not optimized to be themost efficient for each treatment. The efficiency of the treatmentrelies on the several aspects such as the amount of PRP used, thelocation of applying the PRP whether it is topical or in any of the skinlayers, and it also depends on the diffusion of the PRP through the skinlayers.

Fractional CO2 laser therapy is based on the theory of fractionalphotothermolysis. It has been used to treat skin problems, such as scarremoval, skin tightening and skin rejuvenation. Two types of fractionallaser treatments are available presently, nonablative and ablative.Nonablative fractional laser is less invasive, provides good clinicaloutcomes but is not sufficient to treat the above-mentioned skinproblems at a single treatment compared to an ablative laser treatment.The ablative fractional laser treatment creates ablative microscopicchannels of thermal injury that causes skin tightening and smoothening.This effect is achieved by collagen remodeling that causes the skin tore-epithelialize. Despite its advantageous over nonablative laser,ablative laser has a longer down time and more adverse reactions forpatients, such as erythema, acne, milia and infection. Hence, theaesthetic field has been concerned about improving the results of skinrejuvenation but shortening the recovery or downtime from the treatment.A few studies have suggested the use of PRP after fractional lasertreatment. (Lee et al. The efficacy of autologous platelet rich plasmacombined with ablative carbon dioxide fractional resurfacing for acnescars: a simultaneous split-face trial, Dermatol Surg, 2011) suggestedfaster healing occurs for the skin areas that have been treated with PRPafter ablative fractional laser treatment for acne scars. Less Erythemawas observed 4 days after the treatment and an improved overall clinicalappearance of acne scaring occurred for PRP treated areas. (Gawdat etal., Autologous platelet rich plasma: topical versus intradermal afterfractional ablative carbon dioxide laser treatment of atrophic acnescars, Dermatol Surg, 2014) compared improvement of acne scars afterablative fractional treatment when PRP was applied topically or injectedintradermally. The same improvement in acne scaring reduction was showedfor both application methods but significantly lower pain levels wereshown for the topical application of PRP after fractional treatment. Theabove-mentioned methods disclose applying PRP after fractional treatmentis completed, but yet no method has suggested to apply PRP into newlyablated channels have been formed by fractional treatment.

SUMMARY OF THE INVENTION

In an aspect, a dual chambered syringe includes an inner barrel defininga first inner chamber, in which the inner barrel has an aperturedstopper at its distal end, the inner barrel being open at its proximalend; a shaft adapted to fit within the inner barrel, the shaft having adistal end which is engageable with the aperture of the stopper; it alsoincludes a device for controlling engaging and disengaging of the distalend of the shaft with the aperture of the stopper; an outer barrelconcentric with the inner barrel defines a second inner chamber, theouter barrel having a distal end for receiving and dispensing fluids anda proximal end into which the distal end of the inner barrel isinsertable into the second inner chamber. The apertured stopper engagesthe second inner chamber of the outer barrel and selectively prevents orpermits the passage of fluids between the outer barrel second chamberand the inner barrel first chamber; the inner barrel has an engageablesurface on its outside surface; and, the outer barrel has operativelyassociated therewith an engaging device for selective engagement anddisengagement with the engageable surface on the inner barrel.

In another aspect, in the dual chambered syringe, the engageable surfaceof the inner barrel is in the form of one of an internal screw thread oran external screw thread, and the engaging device engages the internalor external screw thread.

In yet another aspect, in the dual chambered syringe, the engagingdevice is a protrusion which is selectively engaged with or not engagedwith the internal or external screw thread.

In another aspect, in the dual chambered syringe, the device forcontrolling engaging and disengaging of the shaft with the aperture ofthe stopper comprises corresponding internal and external screw threadson one of the outside of the shaft and the interior of the first innerchamber.

In yet a further aspect, in the dual chambered syringe, the inner barrelis movable in distal and proximal directions by pushing or pulling theinner barrel along the longitudinal axis of the outer barrel or byturning the inner barrel in either direction when the engaging deviceengages the inner barrel engageable surface.

In a further aspect, in the dual chambered syringe, the outer barreldistal end receives a dispensing apparatus, the dispensing apparatusdispensing fluids from the syringe on skin and tissue surface.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate schematic drawings of the dual chambersyringe in closed and open position respectively.

FIG. 2 illustrates a schematic drawing of a brush delivery system to beconnected to the dual chamber syringe.

FIG. 3 illustrates a schematic drawing of a sponge delivery system to beconnected to the dual chamber syringe.

FIG. 4 illustrates a schematic drawing of a flexible brush deliverysystem to be connected to the dual chamber syringe.

FIGS. 5A and 5B illustrate schematic drawings of a spiral deliverysystem to be connected to the dual chamber syringe.

FIG. 6 illustrates a schematic drawing of a ballpoint head deliverysystem to be connected to the dual chamber syringe.

FIG. 7 illustrates a schematic drawing of a micro-needles deliverysystem to be connected to the dual chamber syringe.

FIGS. 8A and 8B illustrate a schematic drawing of a micro-needles pendelivery system to be connected to the dual chamber syringe.

FIGS. 9A and 9B illustrate schematic drawings of a micro-needles rollerdelivery system to be connected to the dual chamber syringe.

FIGS. 10A and 10B illustrate an embodiment for combining PRP delivery inconnection with a fractional laser treatment.

FIG. 11 illustrates an alternative embodiment of a sealing element forthe syringe of FIGS. 1a and b.

FIGS. 12A, 12B, and 12C illustrate a further embodiment of a dualchamber syringe.

FIG. 13 illustrates a section of the skin after fractional lasertreatment.

FIGS. 14A and 14B illustrate a laser treatment system and handlecombined with PRP and PPP treatment.

FIGS. 15A, 15B, 15C, and 15D illustrate a method of treating cellulitecombined with PRP and PPP treatment.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1A illustrates a dual chamber syringe 100 according to the presentinvention. A first main chamber 104 is defined by the interior portionof syringe barrel 102. As can be appreciated by reviewing FIG. 1A, thesyringe barrel 102 has a fixed maximum volume. However, the effectivevolume, that is, the volume which is available to contain material, isdefined by the position of the syringe piston 106 positioned within thebarrel 102. The syringe piston 106, in a conventional manner, canslidably and sealably move within the syringe barrel 102. The syringepiston 106 position within the barrel may change the effective volume ofthe main chamber 104 to anywhere from its maximum volume to zero shouldthe piston be pushed towards the distal end 125 of the barrel. Accordingto the present invention, the syringe piston 106 is of a hallowconstruction. The hollow piston 106 defines therein a sealed andslidable moving secondary chamber 108. The slidable secondary chamber108 changes the effective volume of the main chamber 104 due to themovement of the piston from the proximal end 123 of the barrel to itsdistal end 125. The main chamber 104 of the syringe and the secondarychamber 108 of the syringe are separated by a barrier 110. The barrierhas an aperture 112 which may establish a fluid communication betweenthe main chamber 104 and secondary 108 chambers. The aperture 112 may besealed by a movable sealing element 114.

The movable sealing element 114 is configured to seal the aperture 112,through the operation of a mechanism which may be contained within thesecondary chamber 108. The sealing element 114 may be connected to ashaft 116 extending along the axis of the secondary chamber and out ofthe proximal end 123 of the secondary chamber 108. The shaft 116 isconfigured to move the sealing element 114 from a sealed-closed positionas shown in FIG. 1A to an open position by pulling a shaft grip 118 tocompress a spring 120 as shown in FIG. 1B. In the illustrated embodimentof FIGS. 1A and 1B, the spring 120 may be seen to be of a type thatpushes the shaft 116 in a distal direction 125 to keep the sealingelement 114 in contact with the barrier 110. In the closed position asshown in FIG. 1A there is no fluid communication between the mainchamber 104 and secondary chamber 108 of the syringe 100. In the openposition as shown in FIG. 1B, in which the shaft 116 has been pulled bythe grip 118 in a proximal direction 123 against the bias of the spring120, fluid communication is established between the main chamber 104 andthe secondary chamber 108. With this configuration, unlike those ofprior art syringes, multiple, controllable movements of material betweenthe main chamber 104 and the secondary chamber 108.

The mechanism of action of the syringe 100 and a method for PRPpreparation in accordance to one aspect of the present invention willnow be described. A barrel discharge opening 122, which is configured toconnect to a standard needle, is positioned on the distal end 125 of thebarrel and may be sealed by a cap 124. By uncapping the dischargeopening 122 can be connected to any needle for the purpose ofwithdrawing the blood. While the shaft 116 is sealing the aperture 112the blood will be contained in the main chamber 104. The blood can beseparated to layers of red blood cells, white blood cells and platelets,and plasma by centrifuging the capped syringe 100 with the blood contentthrough any conventional centrifuge. After the centrifugation the layerswill be separated according to the specific gravity of each component.For separating the red blood cells from the white blood cells, plateletsand plasma the following procedure may be performed with the syringe:while keeping the discharge opening 122 sealed with the cap 124, theshaft 116 is manually manipulated in a proximal direction 123 to movethe sealing element 114 out of the aperture 112. While maintainingaperture 112 open, the piston 106 is pushed in a distal direction 125against the layers in the main chamber 104 in order to decrease the freevolume of the main chamber 104. The layers located in the proximal end123 of the main chamber 104 will be moved to the secondary chamber 108.When reaching the limit line between the red blood layer and the whitecells-plasma layer the shaft grip 118 is released to allow the sealingof the aperture 112 by the sealing element 114. The cap 124 is removedfrom the syringe 100 and the piston 106 is pushed towards the distaldirection 125 to extrude the red blood cells layer. The syringe 100 iscapped again with the cap 124 and the shaft 116 is manipulated againtowards the proximal end 123 to unseal the aperture 112 and establishthe fluid communication again between the main 104 and the secondary 108chambers. By keeping the aperture 112 open and by retracting thehollowed piston 106 back, since the barrel head 122 is sealed, vacuum isestablished in the newly-formed free space in the main chamber 104 whichin turn sucks the white cells, platelets and plasma layer to into themain chamber 104. The centrifugation process can be done again to thecontent of the main chamber 104, this will allow a further concentrationof the platelets as its specific gravity is higher than the plasma. Thesame process of separation between layers into two chambers can be doneagain to separate the platelets layer in the main chamber 104 from theplasma layer in the secondary chamber 108. The PRP layer is now ready tobe applied to any area by connecting the barrel head 122 to any of thedelivery systems further described in FIG. 2 to FIG. 9.

Topical Application Delivery Systems

FIG. 2 illustrates a brush delivery system 200 that can be connectedthrough a luer lock opening 202 to any matching connection. The materialcan be pushed through the luer lock opening 202 towards the bristles204. By moving the bristles 204 on any surface, the material will bespread to form a layer topically covering the surface.

FIG. 3 illustrates an embodiment of sponge delivery system 300. Thesponge delivery system 300 can be connected through a luer lock opening302 to any matching connection. The material passes through the luerlock opening 302 towards a sponge head 304, the sponge head consists ofpores 306 having either the same size or different sizes. The pores 306will deliver the material contained in them when pushed against anysurface as the sponge head 304 will compress and squeeze the materialinside the pores 306.

FIG. 4 illustrates a flexible brush delivery system 400. The flexiblebrush delivery system 400 can be connected through a luer lock opening402 to any matching connection. The material passes through the luerlock opening 402 to a container 404. The material will be deliveredthrough flexible filaments 408 by passing through flexible filamentsopenings 406. Each of the flexible filaments 408 will apply the sameamount of material on any surface by moving the flexible filaments 408in the desired direction in parallel to the surface.

FIG. 5A illustrates a spiral delivery system 500. The spiral deliverysystem 500 can be connected through a luer lock opening 502 to anymatching connection. The material passes through the luer lock opening502 towards a head 504. FIG. 5B shows a bottom view of the head 504, thematerial extrudes through the apertures 506 while a spiral protrusion508 spread the material on the surface. The head 504 can be moved in anydirection in parallel to the surface and can also be rotated forapplying circular massage on the surface.

FIG. 6 illustrates an embodiment for a ballpoint head delivery system600. The ballpoint head delivery system can be connected through a luerlock opening 602 to any matching connection. The material passes througha container 604 and divides to balls openings 606 for being extruded andapplied to the surface. The balls openings 606 may be made of rigidmaterial for applying a massage to the surface being pushed against. Avibrational movement can be combined with the parallel movement of theballpoint head delivery system 600 for applying a massage and assist inimproving the diffusion of the material through the surface.

Injection Delivery Systems

The following embodiments describe delivery systems for injection todifferent skin layers as the needle's length in any of the embodimentscan be changed to allow the penetration to desired skin layer and theapplication of any material especially PRP. Needles described herein mayalso be configured to deliver radio frequency (RF) treatment to the skininto any of the skin layers as known to the skilled person in the art. Acombined PRP and RF treatment may be done by injecting PRP to the siteof RF treatment before, during or after the injection of the PRP. RFneedles may have one or more conductive surfaces (electrodes) configuredto deliver RF energy to the skin. One such conductive electrode may belocated at the tip of the needle proximal to its injecting end. In thiscase the PRP and RF targets adjacent tissue on approximately the sameskin layer. According to another aspect of the invention, conductiveelectrodes may be located proximally to the tip of the needle configuredto deliver RF energy to tissue area located above the tissue which istargeted by the PRP. In a combined RF and PRP treatment, PRP should beprotected thermally to avoid thermal damage to the PRP. According to oneaspect of the invention, needle array may be divided into at least twogroups. At least one group of needles may be configured to deliver RFtreatment only while at least one group of needles may be configured todeliver PRP only. As mentioned above, another way to protect the PRPfrom the elevated temperature of the RF treatment may be achieved bykeeping a certain distance along the needle between the PRP needledelivery end and the location of the RF electrode of such micro-needle.During operation, PRP injection and RF treatment may be delivered intothe tissue in a sequence which is designed to avoid overheating of thePRP, whether located in a delivery system or already injected into thetissue, either by cooling the delivery system and/or the tissue or byallowing the heat to diffuse from the needle or tissue before PRP isdelivered through or into it. According to another aspect of theinvention a combined fractional RF treatment may be delivered beforeduring or after the delivery of the PRP.

FIG. 7 illustrates an embodiment for micro-needles delivery system 700.The micro-needles delivery system 700 can be connected through a luerlock opening 702 to matching connection. The material can be pushedthrough the luer lock opening 702 towards the container 704. Thematerial will be divided and extruded micro-needles 706 as the sameportion will be delivered by each needle to the skin layer where themicro-needles 706 tip is positioned.

FIG. 8A described a micro-needles pen delivery system 800. themicro-needles pen delivery system 800 extrudes the material throughmicro-needles 802. Any syringe can be inserted to a container 804 wherethe material can be pushed manually or automatically from the syringetowards the micro-needles 802. In a closed position, the micro-needles802 are covered with a safety ring 806 to secure the micro-needles 802and prevent the penetration to an undesired surface. In an openposition, as shown in FIG. 8B, the micro-needles 802 will be pushedtowards the distal end of the micro-needles pen delivery system 800 andcan be penetrated to the skin. The micro-needles pen delivery system 800can either be manually operated to allow the penetration of themicro-needles 802 through the skin, or automatically operated bycontrolling the speed of the penetration and un-penetration of themicro-needles 802 through the skin layers. The automatic operation ofthe needles pen delivery system 800 is thought to maximize theefficiency of the treatment and reduce the pain of the micro-needles 802penetration.

FIG. 9A illustrates a micro-needle roller delivery system 900. Themicro-needle roller delivery system 900 can be connected to any syringeby a luer lock opening 902. The material is pushed and extruded througha hollowed channel 904 to reach a roller head 906. The roller head 906consists of micro-needles 908 that covers the outer surface area. themicro-needles 908 deliver the material only through the needles row thatpenetrates the surface, the mechanism of action for this device will befurther described below: the user grabs a handle 910 that is connectedto the hollowed channel 904 and the roller head 906 by a fixed angle γthat allows convenient grip for moving the roller head 906 against aparallel surface. By manually or automatically controlling the materialpassage from a container 912, the material will pass through the luerlock opening 902 and the hollowed channel 904, reaching the roller head906 and will be injected through the micro-needles 908 only to thepenetrated surface area. by moving the handle 910 in parallel to thesurface, the roller head 906 will rotate and allows the penetration ofnew row of micro-needles 908 to the surface when the last row will nowdeliver the material while all the others row are sealed. FIG. 9B showsa detailed illustration for the mechanism of passing the material onlythrough the penetrating micro-needles row 914. The roller head 906consists of openings 916 directed and fixed perpendicular to the surface920. When the micro-needles 908 rotates, micro-needle row openings 918become conjugated with the openings 916 and allow the passage of thematerial through this micro-needles row 914. in the phase of rotatingthe roller head 906 to move between different micro-needles rows 908,the openings 916 is sealed by the roller head 906 inner wall and do notallow the passage of the material.

FIGS. 10A and 10B illustrate the application of PRP or other material incombination with a laser fractional treatment. As can be seen in thefigures, a housing 1001 may be placed in contact with the skin surface1000. The housing 1001 may include a laser fractional treatment head1002 which may be of any known type, including the fractional treatmentapparatus described in U.S. Patent Publ. No. 2012/0065551, the entiretyof which is herein incorporated by reference. The housing 1001 along mayinclude a syringe 1006 of the type described in the present applicationconnected by tubing 1004 to an outlet within housing 1001. In addition,a source of pressure and/or vacuum 1008 with its conduit 1010 may alsobe connected to the housing 1001, as seen by the openings 1004, 1010 inFIG. 10B.

In operation, the fractional laser 1002 may be activated and eitherbefore, simultaneously with or after the fractional laser has beenactivated, the syringe, which may contain a supply of PRP, alsoactivated by pushing on a plunger manually or using suitable mechanicaldevices. Thus, as “channels” are formed in the skin surface 1000 by thefractional laser, amounts of, for example, PRP may be forced into thoseformed “channels” before the channels close following laser activation.The source of pressure/vacuum may also be activated to enhance deliveryof the PRP into the “channels” formed.

FIG. 11 illustrates an alternative arrangement of the movable sealingelement 114 of FIGS. 1A and 1B. In FIG. 11, in place of theconically-shaped sealing element 114 which mates with a similarly shapedaperture in barrier 110, an externally-threaded sealing element 114 amates with an internally-threaded opening 112 a in barrier 110 a. Afurther sealing flange 118 a is placed proximally of the sealing element114 a to assure good sealing quality. In operation, in order to allowcontents of the main syringe body to enter or be mixed with contents inthe syringe piston (as those elements are shown in FIGS. 1A and 1B), thethreaded element 114 a is turned, by way of example, in the direction116 a. This causes the threaded element to disengage from the barrier100, and then be able to be moved in the directions 119 a. Thisarrangement may be particularly useful for applications in whichseparation of the two chambers must be assured, such as in the deliveryof drugs whose powder and liquid components must be kept separated untilmixed and administered.

Further Syringe Embodiments

Turning now to FIGS. 12A and 12B, these figures illustrate a secondsyringe embodiment 1200. Like the syringe 100 of FIGS. 1A and 1B, thesyringe 1200 includes a syringe barrel 1202 and a needle 1204. Thesyringe also includes a syringe piston 1210 which is fitted withinbarrel 1202. Like the syringe barrel 106 of FIG. 1A, the syringe barrel1202 is not solid but hollow and capable of containing materials. At thedistal end 1205 of the barrel is fixed by any suitable means (likegluing, heat shrinking, etc.) a stopper 1214 with one or more aperturesor a holes therethrough formed along an axis parallel to the barrellongitudinal axis. The stopper 1214, like its counterpart 112 of FIG.1A, is made to fit at the distal end of the barrel and prevent theescape of fluids either to outside of the syringe or into the piston1210 internal volume.

The piston 1210 shown in FIG. 12A includes an external screw thread 1209formed on the outside of the barrel and covering the majority of thebarrel. In an alternative arrangement, instead of an external screwthread an internal screw thread 1211 may be formed into the barrel 1212of FIG. 12A. In addition, an engageable switch 1208 seen in FIGS. 12Aand 12B includes a holder 1206 which mounts the engageable switch on thesyringe barrel 1202. The holder and engageable switch may be mounted onsyringe barrel by any suitable joining device, such glue orheatshrinking or welding. When mounted in the holder 1206, the switch1208 is movable in directions 1219. The switch 1208 may also include anengaging tooth 1218. While one tooth is shown in FIG. 12B, it is to beunderstood that a greater number may be employed.

The purpose of the engaging tooth 1218 is to selectively engage eitherthe internal screw threads 1211 or the external screw threads 1209. Theinteraction of the tooth 1218 and the internal or external threads 1209or 1211 will be explained below. FIG. 12A also illustrates a shaft 1216that fits within the internal space of the barrel 1210 or 1212 and isinsertable though the proximal end 1207 of barrel 1210. As mentioned,the stopper 1214 includes a hole 1215 therethrough (see FIG. 12C) alongthe central axis of the barrel 1210 that allows or restricts the passageof fluids from the syringe barrel interior to the interior of the barrel1210 and vice versa. Whether fluids may flow or not flow between thebarrels is determined by the position of shaft 1216. Shaft 1216 at itsdistal end includes a protruding member 1220. The shaft 1216 is movablein directions 1222 within the barrel 1210. Movement may be by way of ascrew thread 1224 which interacts with a complementary screw thread (notshown) within the barrel 1210 and may be located towards the proximalend 1207 of the barrel. Other devices, such as a pressure fitted shaftmay be implemented. In any case, turning the shaft in a clockwisedirection 1225 may cause the shaft to move in direction 1226 within thebarrel 1210. At some point the protruding member 1220 will enter thehole or aperture in the stopper or the hole in the distal end 1205 ofthe barrel and prevent fluid interaction between the two chambers.Turning the shaft in the opposite direction will permit fluidcommunication between the two chambers. A left hand or a right handscrew may be implemented as desired.

Unlike the embodiment of FIGS. 1A and 1B, the embodiment of FIGS. 12Aand 12B has the advantage of less parts and less moving parts. In theembodiment of FIGS. 1A and 1B, as described above, after eachcentrifugation, the process of separation of components is done bypushing the inner barrel in a distal direction towards the distal end(see FIG. 1A). It may be difficult to precisely gauge where one type ofblood component ends, and a second type begins. This is true for thefirst centrifugation to discern the red blood cells/white cells-plasmaline and in the second centrifugation to discern the line betweenplatelet rich and platelet poor plasma. With the simple “push-pull” ofthe inner barrel in the FIG. 1A embodiment, it may be easy to“overshoot” the line and that may cause undesirable mixing of bloodcomponents.

In the embodiments of FIGS. 12A and 12B, the syringe may be used ineither a “push-pull” mode or a more precise “screw” mode. For example,after centrifuging the second time, the inner barrel may be advanced ina distal direction 1228 by pushing. However, as the distal portion ofthe inner barrel approaches the rich/poor PRP line, the user may moveengageable switch 1208 to cause tooth 1218 to enter into or betweeninternal or external threads 1209 or 1211. Once this is done, the barrelcan no longer be pushed in a distal direction or the opposite directionin fact. However, by turning the inner barrel by grasping knurled knob1230 and turning it in a clockwise direction (if a right-hand groove orscrew thread), will cause the inner barrel to advance in a distaldirection in a more controlled manner so as to prevent the type ofintermixing discussed above. When the “screw” function is not needed,such as, for example, when blood is being taken from the patient, thetooth is disengaged from the threads 1209 or 1211. The embodiment ofFIGS. 12A and 12B also does away with the spring 120 shown in FIG. 1Aand the need to compress and hold the spring 120 in a compressed statein certain operations, thus allowing the blood separation process to besmoother with the simple “on/off” screw arrangement in the shaft 1216described above.

Once the needle 1204 has been removed from the distal end of barrel1202, any of the application accessories shown in FIGS. 2 through 9B maybe fitted onto the distal end which can then dispense PRP onto a skin orother tissue site. A luer-type lock may be fitted or otherwiseincorporated onto the distal end to accommodate these accessories. Also,once needle 1204 has been removed the syringe may be fitted ontoconnector 1004 of the fractional energy deliver device shown in FIGS.10A and 10B.

The mechanism of action of the syringe 1200 and a method for PRPpreparation in accordance to one aspect of the present invention willnow be described. A barrel discharge opening is configured to connect toa standard needle 1204, and is positioned on the distal end of thebarrel 1202 and may be sealed by a cap, not shown but similar to cap 124in FIG. 1A. By removing the cap, the discharge opening of the distal endof barrel 1202 can be connected to any needle for the purpose ofwithdrawing blood while the shaft 1216 and its protuberance 1220 issealing the aperture in the stopper 1214 so that blood will be containedin the main chamber of barrel 1202. The blood can be separated intolayers of red blood cells, white blood cells, platelets and plasma bycentrifuging the capped syringe 1200 with the blood content through anyconventional centrifuge.

After a first centrifugation, the layers will be separated according tothe specific gravity of each component. For separating the red bloodcells from the white blood cells, platelets and plasma the followingprocedure may be performed with the syringe: while keeping the barrelhead sealed with the cap, the shaft 1216 is manually manipulated in aproximal direction by turning it in a direction opposite to arrow 1225(for a right hand thread) to move the sealing element 1220 out of theaperture in the stopper 1214 or the aperture in distal end 1205. Whilemaintaining the aperture open, the piston 1210/1211 is pushed in adistal direction 1226 against the layers in the main chamber in order todecrease the free volume of the main chamber of outer barrel 1202. Thismay be done by either pushing the barrel 1210/1211 in a distal directionand/or engaging the threads 1209/1211 on the barrels 1210/1211respectively with the tooth 1218 of assembly 1208 by moving it in adirection so that the tooth enters the threads 1209/1211. Using thethreads allows for very precise movements so that only those bloodcomponents (like PRP) enter into the barrel 1210/1212. The layerslocated in the proximal portion of the outer barrel will thus be movedto the secondary chamber 1210/1212.

When reaching the limit line between the red blood layer and the whitecells-plasma layer, the shaft 1216 is turned in direction 1225 to sealthe aperture in the stopper 1214 by the sealing protuberance 1220. Thecap is then removed from the syringe 1200 and the piston 1210/1211 ispushed towards the distal direction 1226 to extrude the red blood cellslayer from the barrel 1202. The syringe is then capped again with thecap and the shaft 1216 is moved again in a proximal opposite direction1226 to unseal the aperture in the stopper 1214 and establish fluidcommunication again between the main barrel 1202 and the secondarybarrel 1210/1211.

By keeping the aperture in the stopper 1214 open and by retracting thesecondary piston 1210/1212 back, since the distal end of the barrel 1202is sealed, vacuum is established in the newly-formed free space in themain chamber of barrel 1202 which in turn sucks the white cells,platelets and plasma layer to into the main chamber of the barrel 1202.The centrifugation process can be repeated again to the contents of themain chamber of the barrel 1202. This will allow a further concentrationof the platelets because its specific gravity is higher than that of theplasma. The same process of separation between layers into two chamberscan be done again to separate the platelets layer in the main chamber ofthe barrel 1202 from the plasma layer in the secondary chamber of barrel1210/1212. The PRP layer is now ready to be applied to an of skin ortissue area by connecting the distal end of barrel 1202 to any of thedelivery systems described in FIG. 2 to FIGS. 10A/B.

After the second centrifugation, the blood components left behindinclude a volume of Platelet Rich Plasma (PRP) as well as Platelet PoorPlasma (PPP). Rather than dispose of the PPP, the PPP may be extractedfrom the syringe and used in known processes to produce fibrin that maybe used to seal wounds or the like into which, for example, PRP has beenapplied, or, in an alternate manner, the PPP is first applied followedby the PRP onto or into the designed skin or other tissue.

In addition, in the event that a dual barrel structure is not required,but only a single (outer) barrel, the mechanism shown in FIG. 12A withthe internal or external threads illustrated on a syringe piston may beretained as well as the locking mechanism described above. In thismanner, in those instances of injection/application of fluids is desiredto be better controlled or metered than with a simple push movement,which has potential problems of injecting a patient with greater aquantity of medicine or other fluid than desired, the screw threads maybe engaged, and the medicine or fluid dispensed in a controlled mannerby rotating the threaded syringe piston. Thus, in the above embodiment,the inner mechanisms within the syringe piston are dispensed with.

Administration of PPP and PRP During Fractional Treatment of the Skin

FIGS. 10A and 10B illustrate and the accompanying text describescombining PRP with fractional treatment. FIG. 14, discussed below,further describes this type of treatment but also adds treatment usingPPP. FIG. 13 illustrates a section of skin after laser fractionaltreatment 1300. Fraction laser treatment may be manipulated to createdifferent channel shapes in the skin. One channel shape 1302 as shownhere contains two distinct hole shapes; a shallow big hole 1304 and adeep narrow hole 1306. While the deep hole 1306 is shown as beingV-shaped, it is to be understood that any suitable shape may be createdand formed in the skin. PRP and PPP may be applied to the channel 1302using various methods to induce skin rejuvenation and wound healing. Afirst method includes applying PPP after its activation, with Thrombinor similar compounds that converts fibrinogen to fibrin, in the shallowbroader hole 1304. Activated PPP creates a sealant layer on the skin andenters the channel 1302. The sealant prevents the channels fromcollapsing after treatment. Other methods may combine the application ofPPP with PRP. Following the application of PPP, the PRP is applied abovethe sealant layer and diffuses through the channel 1302 to reach thedeep narrow hole 1306.

In the same manner, the PRP may be applied to the skin 1300 prior to thePPP application. The PRP diffuses through to the deep narrow hole 1306and initiates the rejuvenation process. Then, the PPP is activated andapplied to the skin 1300. The PPP enters the channel 1302 and seals theshallow broader hole 1304.

Finally, the PRP and PPP may be mixed before the application and appliedsimultaneously to the skin 1300.

FIG. 14A illustrates laser treatment system combined with PRP and PPPapplication. The laser system 1402 is connected to a handle 1404 througha delivery mean 1406. The delivery mean 1406 delivers the laser energyto the handle 1404. The handle 1404 is connected to a disposable housing1408 that contacts the patient skin during the treatment. The disposablehousing covers two nozzles 1410 and 1412 that apply PPP and PRP to theskin during the treatment.

FIG. 14B illustrates one embodiment of the handle 1404 for applying PPPand PRP using air pressure. The handle 1404 includes the disposablehousing 1408 that is connected to a laser scanner or beam splitter 1414.The laser scanner 1414 receives the laser energy and apply itfractionally to a section of skin 1416. The disposable housing covers atleast one PRP nozzle 1418, at least one PPP nozzle 1420 and at least oneactivator nozzle 1426. PPP nozzle 1420 and PRP nozzle 1418 apply the PPPand PRP respectively during or after the treatment to the skin section1416. The PRP and PPP are inserted into the nozzles 1418 and 1420through sealed rubber barriers 1422 and 1424 respectively to preventcontamination of the materials. To activate the PPP, an activator suchas thrombin is inserted through nozzle 1426 and is separated from thePPP nozzle 1420. The activation of PPP will be initiated after theapplication of the PPP and the activator. For delivering PPP, PRP andactivator, air pressure is applied inside the disposable housing 1408through an air pressure aperture 1428. The air pressure allows sprayingof PRP, PPP and activator from at least one aperture for each material1430, 1432 and 1434. When spraying, the materials are mixed, and the PPPis activated.

Treatment of Cellulite

Cellulite is the accumulation of fat within a connective tissue. The fatgrows and causes alterations of the topography of the skin that arecharacterized by a padded “bumps” appearance. Many treatments aim todisconnect the connective tissue to allow a smoother appearance of theskin. These treatments are mostly invasive and require a long recoverytime.

FIG. 15A illustrates a method of treating cellulite combined with PRPand PPP application. The treatment device 1500 is placed on a section ofskin 1502. Part of the skin 1504 is sucked into chamber 1506 in thetreatment device 1500. The chamber 1506 includes a port 1505 which isattached to a source of vacuum to draw the skin 1504 into the chamber1506 of treatment. The chamber includes a sealable aperture 1508 toallow the insertion of a needle 1510 and for it to move it back andforth and/or horizontally to the sides within the chamber 1506. Theneedle 1510 is inserted into the aperture 1508 and invasively enters thepart of skin 1504. The needle moves in x-y direction 1507. The movementof the needle 1510 disconnects connective tissue 1512 to allow“relaxation” of the skin and create a smoother appearance of the skin1504. PRP and PPP can be applied to the treated area by any means. Onemethod is to apply PPP, PRP and an activator, with no limitation to theorder of application, on top of treated section of skin 1504 during thetreatment. Another method is to apply PPP, PRP and an activator, with nolimitation to the order of application, to the section of skin 1504through the needle 1510 after treatment with the needle. The PRP can bealso applied inside the treated area 1504 while the needle 1508disconnects the connective tissue 1512; afterwards, the PPP can beapplied with the activator on the surface of the skin 1504 to seal thewound caused by the needle 1510 insertion. Other variations may beapplied.

The needle 1510 is further illustrated in different embodiments in FIG.15C and FIG. 15D. FIG. 15C shows a hollowed shaft 1520 that has anopening 1522 next to a blade 1524. While or after the blade 1524disconnects connective tissue 1512, the PRP, PPP and activator can beapplied through opening 1522.

FIG. 15D shows another embodiment of the needle 1510. One shaft 1526 andone hollowed lumen 1528 are connected to each other in parallel. Theshaft 1526 ends with a blade 1524 that is used to disconnect theconnective tissue 1512. The hollowed lumen 1528 may be used to applyPRP, PPP and activator through aperture 1530 to the skin 1504 during thedisconnection of the connective tissue 1512 or after the treatment forenhancing wound healing.

FIG. 15B shows a front view of the aperture 1522 or 1530 in the tip ofthe needle 1510. The aperture 1522 or 1530 may be also configured toinclude a number of lumens, for example, at least one nozzle fordispensing PRP 1514, at least one nozzle for dispensing PPP 1516 and atleast one nozzle for dispensing activator 1518. The respective aperture1522 or 1530 may apply the above materials while the needle 1510 ismoving in x-y directions 1507 within skin section 1504.

Example 1

Three ml of blood were withdrawn using a syringe as described in thepresent application and shown in FIGS. 1A and 1B from the patient andwere mixed with Heparin to prevent coagulation. The platelets count inthe whole blood was found to be 326×10³ in mm³. The syringe was thencapped and centrifuged for 12 minutes at 1000 RPM (Rotofix 32a with 15ml tubes adaptor, Hettich, Germany). After centrifugation the blood andplasma were found to have separated in the syringe with the red bloodcells layer having been moved to under the plasma layer. The plasma wasthen transferred to the inner chamber 106 of the syringe as describedherein. Once the inner chamber's content was separated from the barrel'scontent, the red blood cells layer were discarded by uncapping thebarrel and pushing the red blood cells out of the syringe using thepiston. The syringe was then capped, and the plasma layer contents movedto the main chamber as described herein. After centrifugation, theplatelets count was found to be 523×10³ in mm³ in the plasma layer. Asecond centrifugation was performed at 2500 RPM for 2 minutes. Aftercentrifugation, the content was found to have separated into a viscouslayer at the bottom of the barrel and a liquid layer above that layer.The liquid layer was moved to the secondary chamber in the same manneras described above. The platelet count for the contents in the mainchamber was measured to be 1364×10³ in mm³. Thus, the platelet countusing the syringe apparatus of the present invention and thecentrifugation process described above increased from 326×10³ in mm³1364×10³ in mm³, a more than four folds increase.

What is claimed is:
 1. A method for preparing a plasma productcomprising: (a) providing a dual chambered syringe comprising: (i) ahollow inner barrel having an open proximal end, a distal end, anddefining a first inner chamber, wherein the inner barrel comprises ascrew thread on its exterior surface; (ii) a hollow outer barrelconcentric with the hollow inner barrel, the outer barrel having aproximal end, a distal end, and defining a second inner chamber; whereinthe inner barrel distal end is adapted to be inserted into the outerbarrel proximal end; and wherein the outer barrel distal end is adaptedfor receiving fluids into and dispensing fluids from the second innerchamber; (iii) a tooth positioned to engage the screw thread when theinner barrel is inserted into the second inner chamber; (iv) anapertured stopper positioned at the inner barrel distal end andproviding a fluid flow path between the first inner chamber and thesecond inner chamber; and (v) a moveable shaft positioned within theinner chamber through the inner barrel open proximal end and adapted toreversibly seal the aperture of the stopper; (b) drawing whole bloodfrom a subject into the second inner chamber by moving the inner barrelin a proximal direction while the apertured stopper is sealed, therebyprevent the whole blood from entering the first inner chamber; (c)centrifuging the syringe to produce a red blood cell fraction and aplasma fraction from the whole blood, where the red blood cell fractionis disposed at the distal end of the second inner chamber; (d) openingthe apertured stopper to provide a fluid flow path between the firstinner chamber and the second inner chamber, and disengaging the toothfrom the screw thread; (e) moving the inner barrel in a distal directionso as to move a first portion of the plasma fraction into the firstinner chamber; (f) engaging the tooth with the screw thread; (g)rotating the inner barrel to move the inner barrel in a distal directionvia the engaged tooth and screw thread so as to move a second portion ofthe plasma fraction into the second inner chamber; (h) sealing theapertured stopper; and (i) dispensing the red blood cell fractionthrough the distal of end of the second inner chamber by moving theinner barrel in a distal direction.
 2. The method of claim 1, furthercomprising: (j) opening the apertured stopper and moving the innerbarrel in a proximal direction to cause the platelet fraction to flowinto the second inner chamber.
 3. The method of claim 2, furthercomprising: (k) dispensing the plasma fraction through the distal of endof the second inner chamber by moving the inner barrel in a distaldirection.
 4. The method of claim 2, further comprising: (k)centrifuging the syringe to produce a platelet rich plasma (PRP)fraction and a platelet poor plasma (PPP) fraction, wherein the PRPfraction is disposed at the distal end of the second inner chamber. 5.The method of claim 4, further comprising: (l) dispensing at least aportion of the PRP fraction from the distal end of the syringe.
 6. Themethod of claim 4, further comprising: (l) moving the PPP fraction intothe first inner chamber through the apertured stopper by moving theinner barrel in the distal direction; (m) sealing the apertured stopper;and (n) dispensing at least a portion of the PRP fraction from thedistal end of the syringe.
 7. The method of claim 5, further comprising:(m) dispensing at least a portion of the PPP fraction from the distalend of the syringe.
 8. The method of claim 6, further comprising: (o)dispensing at least a portion of the PPP fraction from the distal end ofthe syringe.
 9. The method of claim 5, wherein the PRP fraction isdispensed through an apparatus comprises a multineedle device comprisinga plurality of hollow needles.
 10. The method of claim 9, wherein theneedles are fixed to a roller delivery system, the roller deliverysystem having an axis perpendicular to the longitudinal axis of thesyringe and wherein the second inner chamber is in fluid communicationwith the roller delivery system and the roller delivery system is influid communication with the hollow needles.
 11. The method of claim 6,wherein the PRP fraction is dispensed through an apparatus comprises amultineedle device comprising a plurality of hollow needles.
 12. Themethod of claim 11, wherein the needles are fixed to a roller deliverysystem, the roller delivery system having an axis perpendicular to thelongitudinal axis of the syringe and wherein the second inner chamber isin fluid communication with the roller delivery system and the rollerdelivery system is in fluid communication with the hollow needles.